MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Catalog Number	4MAXC
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 4max reperfusion catheter (4maxc).During the procedure, prior to advancement into the patient, the physician began flushing the 4maxc with a continuous flush of saline and it was reported that the 4maxc was leaking at a proximal portion of the 4maxc, just past the hub.The physician then noticed that the 4maxc was broken into two pieces and connected by a wire, just past the hub.The 4maxc was therefore removed and was not used in the procedure.The procedure was completed using another 4maxc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 4maxc was fractured beneath the strain relief approximately 3.0 cm from the hub.Yield marks were present near the fracture site.The distal tip was shaped.Conclusions: evaluation of the returned 4maxc revealed a fracture beneath the strain relief.Yield marks were present near the fracture site, indicating the device likely kinked prior to fracture.If the device is forcefully mishandled at extreme angles during removal from its packaging hoop or otherwise mishandled during preparation for a procedure, damage such as a kink may occur.If a kinked device is further manipulated, it may worsen to a fracture.The fracture likely contributed to the reported leaking during the procedure.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8589109
• Report Number: 3005168196-2019-00896
• Device Sequence Number: 1587448
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 4MAXC
• Device Lot Number: F87489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005